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NCT Number: NCT06382441

A Tele-exercise Program for Breast Cancer Survivors

The research protocol outlines a pilot study for a home-based and group-based tele-exercise program designed for breast cancer survivors. The study is a randomized controlled trial (RCT) led by Dr. Yang Gao from Hong Kong Baptist University, with multiple other investigators from Kwong Wah Hospital and the university itself.

Breast cancer is identified as the most prevalent cancer among women globally and in Hong Kong. The document states that adjuvant therapies post-surgery, such as radiation and chemotherapy, can have both short-term and long-term side effects, which may affect the survivors' physical and mental health.

The study is based on evidence that physical activity levels often decrease after a breast cancer diagnosis and that exercise can mitigate the side effects of treatment, improving health and quality of life. The pilot aims to test the acceptability and feasibility of a 12-week tele-exercise program that combines psychological theories and behaviour change techniques, transitioning from supervised to unsupervised exercise to build sustainable exercise habits.

The study will enrol 24 patients, randomly assigning them to an intervention group or an active control group. The intervention group will receive 12 online training sessions plus 4 psychological counselling sessions, whereas the control group will receive educational essays on exercise and health.

The training sessions for the intervention group will include various exercises with increasing intensity and duration over the 4 weeks, monitored by a pulse oximeter to ensure exercises are done at the appropriate heart rate. The sessions will be led by qualified coaches, with Dr. Gao overseeing quality control.

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Key information

Conditions

Behavior, Health Behavior Health Behavior

Age range

40 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Xiong Zhennan, Kowloon Tong, Kowloon, Hong Kong

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About this study

It is a prospective and pilot study of RCT. It will be a pilot to test the acceptability and feasibility of a two-armed tele-exercise RCT to mitigate symptoms and improve health for breast cancer survivors. In this study, outcome assessors and data analysts will be masked from the allocation results. The pilot will recruit 24 patients and randomly assign them to an intervention group (Group A) and an active control group (Group B). All participants in both groups will continue receiving usual care from the study hospital during the study period. Additionally, those in Group A (intervention) will receive the tele-exercise (12 home-based online training sessions + 4 psychological counselling sessions), while those in Group B (active control) will receive 4 essays on exercise and health. Outcome measurements will be repeatedly performed before and after the intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females aged 40-64 years old;
  • Within 6 weeks after completion of chemotherapy;
  • Without severe anemia;
  • Without cancer metastasis;
  • Able to read and communicate in Cantonese or Mandarin;
  • Smartphone users.

Exclusion criteria

  • With any medical, physical and psychological conditions that may limit participation (e.g., uncontrolled severe cardiovascular disease, schizophrenia, severe neurological dysfunction, etc.).

Treatment and study plan

tele-exercise

Behavioral

It is a prospective and pilot study of RCT. It will be a pilot to test acceptability and feasibility of a two-armed tele-exercise RCT to mitigate symptoms and improve health for breast cancer survivors. In this study, outcome assessors and data analysts will be masked from the allocation results. The pilot will recruit 24 patients and randomly assign them to an intervention group (Group A) and an active control group (Group B). All participants in both groups will continue receiving usual care from the study hospital during the study period. Additionally, those in Group A (intervention) will receive the tele-exercise (12 home-based online training sessions + 4 psychological counselling sessions), while those in Group B (active control) will receive 4 essays on exercise and health. Outcome measurements will be repeatedly performed before and after the intervention.

Primary outcomes

  1. Acceptability (quantitative)

    Time frame: baseline, 13 weeks

    Participants rated intervention regarding the aspects of satisfaction, enjoyment, perceptions of safety, difficulty, tolerability of treatment, adverse events using a 5-Liker questionnaire, mean score was used to assess, and higher score indicates greater acceptability.

  2. Acceptability (qualitative)

    Time frame: baseline, 13 weeks

    Participants rated intervention regarding the aspects of satisfaction, enjoyment, perceptions of safety, difficulty, tolerability of treatment, adverse events by interviews.

  3. Recruitment rate

    Time frame: baseline, 13 weeks

    The proportion of eligible participants who are enrolled at baseline of the study.

  4. Retention rate

    Time frame: baseline, 13 weeks

    The proportion of enrolled participants who are present throughout the full length of the treatment.

  5. Attendance rate

    Time frame: baseline, 13 weeks

    The proportion of total sessions offered to participants to the actual number of sessions participants attended.

  6. Compliance rate

    Time frame: baseline, 13 weeks

    Participants' level of adherence to the content, frequency, duration, and coverage of the treatment as delivered by the research team. Assessed by percentage of participants who complied with intervention procedures.

Secondary outcomes

  1. Cardiorespiratory fitness

    Time frame: baseline, 13 weeks

    estimated by the 6-minute walk test, primary outcome of the main study

  2. muscle strength

    Time frame: baseline, 13 weeks

    upper extremity muscle strength by the hand grip test and lower extremity muscle strength by the timed stand test

  3. balance

    Time frame: baseline, 13 weeks

    Assessed using the Single Leg Stance Test. It is used to assess static postural and balance control and widely used in clinical settings to monitor neurological and musculoskeletal conditions.

  4. % body fat

    Time frame: baseline, 13 weeks

    A Body Composition Analyzer (InBody 270)

  5. skeletal muscle mass

    Time frame: baseline, 13 weeks

    A Body Composition Analyzer (InBody 270)

  6. height

    Time frame: baseline, 13 weeks

    Measured using a portable stadiometer

  7. Shoulder joint range of motion (ROM) of affected side

    Time frame: baseline, 13 weeks

    An arm goniometer will be used to measure shoulder joint ROM in forward flexion, internal rotation, external rotation, and abduction, following the Struyf and Meeus' recommendations to conduct the goniometric shoulder joint ROM measurements

  8. Limb circumference and lymphedema

    Time frame: baseline, 13 weeks

    Arm circumference will be measured with a non-stretch tape at styloid and every 10 cm intervals from the ulnar styloid up to 40 cm distally 19. D Lymphedema will be defined as a more than 2 cm between-arm difference in arm circumference at any measurement point.

  9. Health-related quality of life

    Time frame: baseline, 13 weeks

    Functional Assessment of Cancer Therapy - Breast (FACT-B) will be used. The total score of FACT-B ranged from 0 t o148. The higher the score, the better the quality of life.

  10. Physical activity level (min/week)

    Time frame: baseline, 13 weeks

    International physical activity questionnaire (short version) was used to calculate physical activity level (min/week), higher scores mean a greater physical acitivity level.

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Registry information

Official study title

A Pilot Study of "a Home-based and Group-based Tele-exercise Program for Breast Cancer Survivors: a Randomized Controlled Trial"

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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